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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05307146
Other study ID # S53126
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2013
Est. completion date January 1, 2035

Study information

Verified date March 2022
Source Universitaire Ziekenhuizen Leuven
Contact Anaïs Van Hoylandt
Email anais.vanhoylandt@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective interventional study with implantation of micro-electrodes to study the brain networks in epilepsy at high spatiotemporal resolution.


Description:

The goal of this trial is to study brain activity in epilepsy at high spatiotemporal resolution. Apart from the epileptogenic network (dysfunctional areas), the investigators will study human brain function. The use of micro-electrode arrays allows to study the human brain a high spatiotemporal resolution, even at the single neuron level. Scientific objectives of the current project: - To record neural signals from macro-electrodes and delineate the epileptogenic network and study brain function during specific tasks. - To record neural signals from micro-electrodes and delineate the epileptogenic network and study brain function during specific tasks. - Identifying pivotal regions for BMI applications and developing online decoding algorithms. - Comparing neural recordings to fMRI activity


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 1, 2035
Est. primary completion date January 1, 2035
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age =18 yo - Epilepsy patients undergoing intracranial electrode placement. - Able to understand the procedure involved and to consent. Exclusion Criteria: - Age < 18 yo - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
macro/micro electrode recording
intracranial macro/micro-electrode placement at the cerebral cortex or in deeper brain areas with te use of macro/micro electrode recording. Macro/micro electrodes are placed at the cerebral cortex or in deeper brain areas in order to precisely identify the epileptogenic focus

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrophysiological recordings: single neuron recordings The investigators will investigate the epileptogenic network by recording neural activity at different spatiotemporal scales and using different modalities. The investigators will be looking at * Electrophysiological recordings:
- single neuron recordings (outcome measure: spike rate)
15 years
Primary Electrophysiological recordings: LFP The investigators will investigate the epileptogenic network by recording neural activity at different spatiotemporal scales and using different modalities. The investigators will be looking at * Electrophysiological recordings:
- local field potentials (LFP) (outcome measure: mainly power in the beta and gamma band, but also alfa and theta band)
15 years
Primary fMRI recordings * fMRI recordings (outcome measure: Blood Oxygen Level Dependent (BOLD) signal increases/decreases)
By performing electrophysiological recordings and fMRI recordings in the same subjects, we will be able to compare both modalities with each other.
15 years
Secondary Neurophysiological study of different brain areas: power gamma band Since electrodes are placed for clinical purposes, the investigators will also use these electrodes to investigate normal neural functions of the human brain: vision, perception and motor.
* Macro-electrodes record local field potentials (LFP). The main outcome measure for visual research is the power in the gamma band. The main outcome measure for motor research is power increase in the beta and gamma band.
15 years
Secondary Neurophysiological study of different brain areas: spike activity * Micro-electrodes and multi-electrode arrays (Utah-array) record local field potentials (LFP) and spike-activity. The outcome measure for spike activity is spike rate. For the local field potentials, the main outcome measure for visual research is the power in the gamma band. The main outcome measure for motor research is power increase in the beta and gamma band. 15 years
Secondary Neurophysiological study of different brain areas: fMRI The outcome measure is blood oxygen level dependent (BOLD) signal changed in response to visual and/ or motor experiments. 15 years
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